Approximately 1.5 million patients are diagnosed with cancer each year in the U.S. Many of these patients will develop metastases to bone during the course of their disease. Now, physicians treating Medicare patients with known or suspected cancer metastatic to bone can much more widely order PET scans using the NaF radiotracer to help formulate treatment plans.

The primary objective of the expanded NOPR is to assess the effect of NaF-PET on how physicians manage the care of their Medicare patients. The project seeks to answer questions about whether NaF-PET results in physicians changing patient care to more appropriate palliative or curative care.

Studies in the past decade have demonstrated that NaF-PET has a higher diagnostic accuracy than conventional bone scans with technetium-99m and also has the advantage of significantly shorter scan times (approximately one hour for NaF-PET and three to four hours for a bone scan). However, these scans have not realized widespread use, in large part, because of a lack of insurance coverage—and most notably Medicare coverage.

After discussions with multiple professional medical societies in June 2009, CMS evaluated the evidence supporting the use of NaF-PET scans for detection of bone metastasis to determine coverage policy. In early 2010, the agency announced its conclusion that the evidence is not sufficient to determine NaF-PET improves health outcomes of beneficiaries with cancer.

However, CMS also determined that the evidence is sufficient to cover the cost of a NaF-PET scan if it is performed through coverage with evidence development (CED) that requires, as a condition of payment, collection of additional data to assess the scan’s impact on patient care.

A previous similar determination by CMS led to the NOPR’s establishment and subsequent participation of over 1,900 PET facilities, data collection on nearly 200,000 FDG-PET scans (as of Dec. 31, 2010) and CMS coverage for the vast majority of FDG-PET indications. The extensive experience of the NOPR investigators and staff, established processes and data collection infrastructure and strong CMS collaboration led the same team to develop the NaF-PET component of the NOPR.

NOPR principal investigator, Bruce Hillner, MD, of Virginia Commonwealth University in Richmond acknowledged, “Having established an extensive infrastructure and workflow processes for the NOPR has greatly facilitated the expansion of the NOPR to include NaF-PET data collection. We’ve been particularly pleased that so many of the NOPR participating institutions have communicated intent to participate.”

All PET facilities currently participating in the NOPR are eligible to participate in the expanded program and new facilities are encouraged to join. Patient registrations will be accepted beginning at 9:00 a.m. on Feb. 7.

For more information, including a listing of NOPR results publications, click here.